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Presented by:
Epstein Becker Green
Telemedicine and Digital Health
In Association With:
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Telehealth and the U.S. Health Care Landscape
The U.S. health care landscape is transitioning from fee-for-service to pay-for-performance (e.g., outcomes, quality) models of care delivery
Increased use of integrated delivery models (e.g., Accountable Care Organizations),bundled payments, medical homes, and readmissions reduction initiatives
Growing consumer demand for in-home care modalities
Telehealth viewed as an efficient and cost-effective care delivery vehicle
Availability, accessibility, and ubiquity of telehealth technologies
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Telehealth Drivers
Increasing Aging (65+) Population• Projected increase in U.S. population from
319 million (2014) to 417 million (2060)• Projected increase in aging population
from 46 million (2014) to 98 million (2060)• By 2030, 1 in 5 Americans 65 and over
Fewer Physicians• Projected shortfall of up to 94,700
physicians by 2025• Projected shortfall of up to 35,600
primary care physicians by 2025• Projected shortfall of up to 60,300 non-
primary care physicians by 2025
Payment for Value / Outcomes• Driven by increased patient costs and
post-acute care strategies designed toreduce readmissions
Ubiquity of Technology Use of Telehealth Outside U.S.
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Benefits of Telehealth
Efficient, Cost-EffectivePatient Care
Collaboration BetweenProviders to Help
Improve Patient Care
Access to Specialty andSubspecialty Care (e.g.,
extending provider reach)
Access for Patients inUnderserved / Rural
Locations
Patient Satisfaction
Cost / PenaltyAvoidance (Value-Based
Purchasing)
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Increasing Access to Care
PRISONS RURALAREAS
DISASTERAREAS
VETERANS
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Usage of Telehealth Services
Patient CareRemotePatient
Monitoring
MedicalEducation of
Providers
ConsumerHealth
Information
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Telehealth Modalities
Modality Description
Real Time(“Synchronous”)
Provider and patient communicate live via videoconferencing. Commonly used forproviding, e.g., telebehavioral health, telehomecare, and telecardiology services.Enables remote consultations (teleconsults) between a variety of primary andspecialty health care professionals.
Store & Forward(“Asynchronous”)
Digital images, videos, audio, and/or clinical data are captured electronically andstored on a patient’s computer / mobile device, and then transmitted securely to aprovider for later study or analysis. Commonly used for providing, e.g.,teledermatology and telepathology services.
Remote PatientMonitoring
Patient uses a system that remotely captures and feeds data / information fromsensors and/or other monitoring devices / equipment to an external monitoringcenter so that providers can monitor the patient remotely. Commonly used formonitoring chronic health conditions, e.g., heart disease, COPD, diabetes, andasthma.
Wearables
Devices that can be worn as accessories or clothing on a person’s body and that havefeatures similar to mobile phones, tablets, and laptops. Wearables offer scanningand sensory components to track physiological functions such as blood pressure orheart rate.
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Legal / Regulatory Issues for Telehealth Providers
Licensure
Scope of Practice
• Physician-Patient Relationships
• Remote Prescribing
Coverage and Reimbursement
Privacy and Security
Fraud and Abuse
Professional Liability
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Licensure and Telehealth
States monitor practices ofhealth care professionals within
their boundaries
State licensure rules run counterto the practice of telehealth,
which transcends geographicalboundaries
Licensure is the process bywhich states validate thecredentials of health care
professionals
Health care professionals who provide servicesvia telehealth modalities generally are subjectto the licensure rules of: (1) the state(s) inwhich their patients are physically located; and(2) the state(s) in which they (the professionals)are practicing.
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Licensure and Telehealth
TraditionalLicense
SpecialTelemedicine
License
Endorsement
RegistrationReciprocity
“BorderingStates”
Exception
ConsultationException
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Various initiatives have attempted toaddress telehealth licensure issues:
• Interstate Compacts (e.g., FSMB,NCSBN)
• Congressional Initiatives
o115th Congress – nothing relevantintroduced to date
o114th Congress –
– VETS Act of 2015 (H.R. 2516 / S.2170)
– TELE-MED Act of 2015 (H.R. 3081/ S. 1778)
• State Legislative Initiatives (150+ in2016)
Licensure and TelehealthOther Initiatives Attempting to Address Telehealth Licensure Issues
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FSMB Interstate Medical Licensure Compact
Designed to facilitate physician licensureportability and practice of interstatetelemedicine services(http://licenseportability.org)
Would create an additional licensurepathway through which physicians couldobtain expedited licensure in Compact-participating states
Intended to complement, not supersede,existing authority of state medical boards
Compact Commission working to establish anadministrative framework
Conceptually similar to Nurse Licensure Compact(https://www.ncsbn.org/nlc.htm)
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APRN Model Compact
Approved May 2015 by Special DelegateAssembly of the NCSBN(https://www.aprncompact.com/)
Would allow APRNs to hold a singlemultistate license with a privilege topractice in other Compact states
Requires enactment by at least 10 statesin order to be effective (currently, 2states have enacted)
Would authorize APRN multistatelicense holders to practice independentof a supervisory or collaborativerelationship with a physician, and wouldextend them prescriptive authority fornon-controlled prescription drugs
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Corporate Practice of Medicine
Liability for Employees andAgents
Professional Liability Insurance
Health Information Privacy andSecurity
Reliability of Technology andTransmissions
Authentication
Scope of Practice
Lack of Uniform / ConsistentTelehealth Standards
Telehealth Professional LiabilityUnique Considerations
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Scope of Practice – An Overview
Generally, a health care practitioner’s “scope of practice” delineates whatmembers of the profession may do and places limits upon the functions thatmembers of the profession may lawfully perform
Each state has its own laws, regulations, and governing bodies that craft andenforce particular scope of practice requirements
Health care professions with defined scope of practice requirements include:
• Physicians
• Nurses
• Pharmacists
• Social Workers
• Emergency Medical Services Personnel
• Midwives
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Scope of Practice –Establishing the Physician-Patient Relationship
Traditionally, establishing aphysician-patient relationship hasrequired at least an initial in-person encounter between aphysician and a patient
Increased use of telehealthtechnologies raises questionsregarding this traditional view ofphysician-patient relationships
• When is a physician “consulting”?
• When is a physician making a“diagnosis”?
• When is a physician “treating” apatient?
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Scope of Practice –Establishing the Physician-Patient Relationship
Establishing aphysician-patientrelationshipdepends on:• Patient’s medical
history• Physician’s
affirmative acts,e.g., examining,diagnosing,treating, oragreeing to treatthe patient
Satisfying theminimum
standard ofcare
Utilizingonline web
portalsdesigned to
diagnose andtreat patients
without aphysical
examination
CollectiveAnalysis:
Legal
RiskManagement
Insurance
Quality
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FSMB Model Policy for the Appropriate Use of
Telemedicine Technologies in the Practice of Medicine
Adopted by FSMB in April 2014; replaced FSMB’s 2002 Model Guidelines forthe Appropriate Use of the Internet in Medical Practice
Provides that in some situations, telehealth technologies can be used in lieuof in-person care, but also provides guidance on key relevant practice issues(e.g., continuity of care, maintaining a patient’s medical record, necessarydisclosures)
On establishing the physician-patient relationship:
• Fully verifying and authenticating location;
• To extent possible, identifying requesting patient;
• Disclosing and validating provider’s identify, credentials, etc.;
• Obtaining appropriate consents from requesting patients after disclosuresregarding delivery models, treatment methods / limitations, etc.
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Are there anyspecial licenses
required toprescribe viatelehealth?
What is thecriteria for
establishing aphysician-
patientrelationship via
telehealth?
Who canprescribe viatelehealth?
What can beprescribed via
telehealth?
Scope of Practice – Remote PrescribingKey Questions
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• Requiring an in-person evaluation or physicalexamination before prescribing online• Some states explicitly require in-person exams• Other states are not so explicit (can physical exam
be provided by other means?)• Permitting physicians to prescribe via telehealth
modalities only if there is a preexisting patientrelationship even if physician is licensed in the statewhere patient is physically located
• Prohibiting prescribing based solely on informationfrom an online questionnaire
• Regulating online prescribing through pharmacy laws• Liberalizing prescribing laws (e.g., VA)
States havedifferent
approachesto
regulatingremote
prescribing
Scope of Practice – Remote PrescribingVarying Approaches by States
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Amended the Controlled Substances Act (21 U.S.C. § 802 et seq.) and regulatesonline prescribing of controlled substances
Specifically prohibits dispensing controlled substances via the internet without a“valid prescription” and provides that a prescription is “valid” only when issued for alegitimate medical purpose and if a physician conducted at least one in-personmedical evaluation of the patient before issuing the remote prescription
Includes certain exceptions considered potentially applicable to telehealth practice;however, many physician-to-patient virtual models of care delivery likely not covered
Describes a process for creating a “special telemedicine registration” that DEA hasnot yet made available to providers seeking to prescribe remotely
• An April 2016 notice indicated DEA had proposed to “amend the registrationrequirements to permit such a special registration” and sought comments;however, no action yet by DEA
Presently, federal prohibition remains a regulatory hurdle for telehealth providersseeking to prescribe controlled substances
Scope of Practice – Remote PrescribingRyan Haight Online Pharmacy Consumer Protection Act of 2008
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Coverage and Reimbursement
Medicare: Currentlyoffers its beneficiaries
the most limitedaccess to telehealthservices; coveragerules are extremely
rigid
Medicaid: 48 statesand D.C. provide at
least some coverageof and reimbursementfor telehealth services
(as of Apr. 2017)
Private Payers: Manyleading private payers
offer coverage andreimbursement fortelehealth services,
although thesepolicies vary widely
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Many states have enacted, or are in the processof enacting, “parity” laws
• Generally require health insurers to cover /reimburse for services provided via telehealth“in a comparable manner” to how the payorwould cover / reimburse for same servicesprovided in person
• 35 states and counting (e.g., CA, GA, HI, MD,MI, OR, VA)
Coverage and ReimbursementPrivate Payer Parity Laws
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How Does Medicare Reimburse for Telehealth?
Limited coverageBeneficiaries must be
present and encountersmust involve interactive
audio and videotelecommunicationsproviding real-time
communication betweenpractitioner and beneficiary
Beneficiaries must be seenat certain, identified
originating sites (e.g.,hospitals, physicians’
offices, FQHCs), in veryrural countiesTelehealth services may be
performed at distant sites onlyby certain identified practitioners
(e.g., physicians, NPs, PAs)
Only certain CPTcodes are
reimbursed
Medicarebeneficiaries are
responsible for co-insurance and
deductible payments
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How Does Medicaid Reimburse for Telehealth?
States have option/ flexibility to
determine whetherto cover telehealthservices and whattypes of telehealthservices to cover
To date, 48 statesand the District ofColumbia provide
at least someMedicaid coverage
of andreimbursement fortelehealth services
States are notrequired to submitseparate SPAs for
coverage of orreimbursement fortelehealth services,provided the state
reimburses forsuch services in
the same manner /amounts as they
do for comparableface-to-face
services
States areresponsible for
ensuring accessand covering face-
to-face visits /examinations by
“recognized”providers in thoseparts of the statewere telehealthservices are not
available
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Fraud and Abuse Laws in a Nutshell
The Anti-Kickback Statute prohibits “remuneration” in exchangefor referrals, purchases, orders, or recommendations forpurchases of items or services directly or indirectlyreimbursed by federal health care programs.
The Stark Law prohibits physician referrals of“designated health services” for Medicare / Medicaidpatients if the physician (or an immediate family member) has a“financial relationship” with the entity.
The False Claims Act prohibits the submission (or causing thesubmission) of false or fraudulent claims to governmental payers.
• Anything downstream from an AKS or Stark violation is a false claim
States may have their own versions of each of these laws, someof which are stricter than the federal standards and some thatapply to all payors, not just government payors (“all payor laws”).
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Consider . . .
• Equipment used to providetelehealth services can be costly
• Distant site providers may beoffered free or discountedequipment from originating siteproviders, other providers, orvendors
• Receipt of free or discountedservices by health careproviders may implicate federaland state fraud and abuse laws
Be Mindful Of . . .
• Anti-Kickback Statute• Physician Self-Referral Law
(“Stark Law”)• False Claims Act• State-Specific Equivalents
Fraud and Abuse ConsiderationsApplication to Providing Telehealth Services
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FY 2017 OIG Work plan noted that Part D spending for compounded topical drugsgrew by more than 3,400 percent between 2006 and 2015, reaching $224 million.This growth in spending, combined with an increase in the number of OIGinvestigative cases involving compounded drugs, suggests the emergence of a fraudrisk
TRICARE paid $23 million for compounds in 2010. Costs skyrocketed to $513 millionby FY 2014, reaching $1.7 billion in the first nine months of 2015, when new controlswent into effect
Scheme involves speaker fees, consulting fees, research study fees, etc. as well astelemedicine doctors providing the keys to unlock the doors to lucrative prescriptionsfor compound medication
Compounding pharmacies often pre-print the prescriptions and send them tophysicians to check a box next to the compounded cream to be used
Private auto and state workers-compensation insurers are new, emerging targets
Telemedicine Fraud TrendsUnderstanding the “Scheme”
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Marketers
Beneficiaries
TelemedicineDoctors
Pharmacies
Telemedicine Fraud TrendsCompound Prescription Drug Scheme
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Government is using:
• civil settlements – mostly in the Middle District of Florida
• criminal prosecutions – spread around the country: MDFL; SDFL, Texas,CDCA; DNJ
Investigations involve an alphabet soup of federal agencies: HHS-OIG; FBI;DCIS; U.S. DOL-OIG; Office of Personnel Management; Department ofVeterans Affairs
Investigators look for:
• Telemedicine physicians writing the same exact prescriptions for multiplefamily members
• Telemedicine physicians writing prescriptions for the marketers
Telemedicine Fraud TrendsGovernment Investigation Tactics
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Investigators look for:
• Physicians making basic mistakes – such as incorrectly spelling their ownname, failing to fill out the prescriptions, or writing prescriptions for thewrong gender
• Use of preprinted forms that have incorrect office addresses – includingstates where they are not licensed
• Physicians writing prescriptions for individuals in numerous states –sometimes including states where they are not licensed
• Same exact prescriptions over and over despite patients age/condition/diagnosis/allergies, etc.
• Beneficiaries who may not want/need the compound prescription creams
Telemedicine Fraud TrendsGovernment Investigative Tactics, cont’d
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In compounding investigations, the government has itseye on:
• Topical scar/pain creams
• Lidocaine ointment and creams
• Diclofenac/Gabapentin gel
• Fluocinonide/Ketamine cream
• Baclofen, cyclobenzaprine, Levocetirizine
• “Migraine” medications
Telemedicine Fraud TrendsRed Flags for Compounded Prescriptions
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Data Analytics: looking for outliers
• Physicians who change prescribing patterns – e.g., ER doctors prescribing lots ofcompounded medication or orthopedic braces
• Physicians prescribing outside of their home states
• Physicians prescribing outside of their specialties
• Out-of-state pharmacies filling medications nationally
• Prescriber/Beneficiary/Pharmacy states are all different
Claims Analysis: looking for rapid increases in claims or a certain number of doctorshave a huge share of the market for a particular product/medication
How does the Government prove these cases?
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Regular ways that the Government proves cases:• Informants/proffers• Review of medical records• Expert review of charts• Recorded calls• Interviews with employees/former employees/beneficiaries• Review of financial records (follow the money trail…..)• Search warrants – e-mails, cloud storage, physical premises
(office/home)• Seizure warrants – cars, watches, jewelry, boats, etc.
How does the Government prove these cases?Cont’d
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Takeaways for Providers
Always ask basic questions:
• Can you identify the address of where the telemedicine company is located?
• Can you identify the first and last names of anyone who works at the telemedicinecompany?
• Did you go through any hiring process other than submitting basic HR paperwork?
• What training/oversight did you receive from the telemedicine company?
• What is the extent of your compliance, HIPAA and fraud/waste/abuse training?
• Do you know the people you are working with, i.e., actually meet them in person?
• When you have a question, who can you call?
Easy Money = HUGE red flag
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Takeaways for Providers (cont.)
Do you have a contract with the telemedicine company? Did you have anattorney vet the contracts?
What are the sources of your payments?
• Fee for service? Other sources of government payment? Widely differentrequirements for Medicare vs. states (Medicaid) vs. TRICARE
• Flat rate commissions?
• Commercial insurance reimbursement?
Are you a W-2 employee or an independent contractor?
Beware of stolen identities (after sending in their medical credentials,physicians have had their identities and medical credentials stolen toauthorize prescriptions without their knowledge)
Physicians cannot be “ostriches in the sand” – jury instruction of “willfulblindness” or “conscious avoidance”
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Takeaways for Patients
Beware of “marketers”
Be aware of the ownership and the privacy of your health records, especiallywhen telemedicine services are provided via “cloud based” proprietaryplatforms
Monitor your EOBs – see who is billing you and for what
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Takeaways for Telemedicine Companies
Be mindful of varying requirements by state, payor, etc.
Ensure that your program / platform adheres to high clinical standards:
• Clinical design
• Board-certified physicians, licensed health care professionals (e.g., psychologists)
• Use of evidence-based guidelines
Develop and implement a rigorous compliance program (e.g., double-blindedpeer review, random auditing by clinical staff members, patient reviews)
Be mindful of remote prescribing of controlled substances – DEA’s jurisdiction & theRyan Haight Online Pharmacy Consumer Protection Act of 2008
Seek and obtain accreditation from national standard-setting organizations(e.g., American Telemedicine Association, National Committee for QualityAssurance, Health Information Trust Alliance)
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About half of all Americans will meet criteria for a diagnosable psychiatric disorder intheir lifetime
According to the Substance Abuse and Mental Health Services Administration(“SAMHSA”), mental illness treatment costs are $100 billion annually, accounting for6.4% of the $1.6 billion spent on health care in the U.S. annually
• Indirect costs (e.g., lost earnings, disability benefits) of mental illness are muchhigher than the direct costs
Approximately 91 million adults live in areas of “psychiatry shortage” in the U.S.
Other factors complicate access to mental illness treatment
• Mental health practitioners (esp. psychologists) aging out of practice
• Mental health practitioners refusing to accept insurance
Mental Illness in the U.S.Prevalence, Costs, and Access to Treatment
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Benefits of Telemental Health
Increased access to mentalhealth practitioners
Breaking down traditionalbarriers of distance, time, andstigma
Giving mental healthpractitioners increased freedom /flexibility and decreasingoverhead associated withproviding services
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Multitude of Licensure Types
Legal / Ethical Considerations
Cultural / Lingual / Diversity Issues
Regulatory Obstacles to Telemental HealthDifferent Considerations, or More of the Same?
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California
•The Board of Psychology’s Notice to California Consumers Regarding the Practice of Psychology on the Internetaddresses various regulatory requirements, including that practitioners must have current, valid licenses to practice inCalifornia
Colorado
•The State Board of Psychologist Examiner’s Teletherapy Policy (§30-1) provides guidance regarding psychotherapythrough electronic means, which includes compliance with all provisions in the state’s Mental Health Practice Act,including licensure
Florida
•The Board of Psychology has issued opinions stating that teletherapy constitutes the practice of psychology requiringFlorida licensure (06-0976), and that a Florida-licensed psychology residing in Michigan could provide telepsychologyservices to patients in Florida (12-0324)
Louisiana
•The State Board of Examiners of Psychologists’ Telepsychology Guidelines (eff. Jan. 2015) require that practitioners are“aware of and in compliance with Louisiana psychology licensure laws and rules”
Nevada
•Assembly Bill No. 292 (eff. July 2015) outlines the Board’s policy regarding telepsychology, stating that practitioners whoprovide services through telehealth to patients located in Nevada are subject to the laws and the jurisdiction of the state,including licensure requirements, regardless of the location from which the practitioner provides such services
Developments in Telemental HealthWhat Are States Doing?
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Telemental Health Privacy and Security Issues
Patient-Provider
Interactions
PatientRecords
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Telehealth Resources
American Telemedicine Association (www.americantelemed.org)
Alliance for Connected Care (www.connectwithcare.org/)
Center for Connected Health Policy (www.cchpca.org)
Center for Telehealth and eHealth Law (www.ctel.org)
eHealth Law & Policy Journal (www.e-comlaw.com/ehealth-law-and-policy/)
Federation of State Medical Boards (www.fsmb.org)
International Society for Telemedicine & eHealth (www.isfteh.org/)
Telehealth Resource Centers (www.telehealthresourcecenter.org/)
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Digital HealthConsiderations forTelemedicine & Beyond
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Telehealth Modalities
Modality Description
Real Time(“Synchronous”)
Provider and patient communicate live via videoconferencing. Commonly used forproviding, e.g., telebehavioral health, telehomecare, and telecardiology services.Enables remote consultations (teleconsults) between a variety of primary andspecialty health care professionals.
Store & Forward(“Asynchronous”)
Digital images, videos, audio, and/or clinical data are captured electronically andstored on a patient’s computer / mobile device, and then transmitted securely to aprovider for later study or analysis. Commonly used for providing, e.g.,teledermatology and telepathology services.
Remote PatientMonitoring
Patient uses a system that remotely captures and feeds data / information fromsensors and/or other monitoring devices / equipment to an external monitoringcenter so that providers can monitor the patient remotely. Commonly used formonitoring chronic health conditions, e.g., heart disease, COPD, diabetes, andasthma.
Wearables
Devices that can be worn as accessories or clothing on a person’s body and that havefeatures similar to mobile phones, tablets, and laptops. Wearables offer scanningand sensory components to track physiological functions such as blood pressure orheart rate.
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FDA Regulation of Digital Health Technologies
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FDA Medical Devices Basics
Medical Device Definition
Section 201(h) of the Federal Food, Drug, andCosmetic Act, defines a medical device as:
"... an instrument, apparatus, implement, machine, contrivance,implant, in vitro reagent, or other similar or related article, includingany component, part or accessory, which is ... [either]
intended for use in the diagnosis of disease or other conditions, orin the cure, mitigation, treatment, or prevention of disease, in manor other animals ... [or]
intended to affect the structure or any function of the body of manor other animals."
It all comes down to the manufacturer’s intended use
FDA Regulates Products Not Services
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Circumstances•How legitimate are non medical uses•Sales volume related to medical use
Actions•Design features (i.e. uniquelyclinical features)•Distribution (e.g. medicalsales and distributionchannels)•Where do your sales peoplevisit (shows and customers)?•Differential pricing
Words•External - labeling, sales lit.advertising, sales pitches•Internal - businessplanning, sales forcememos, training
Intended Use – Look at Totality of Circumstances
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Intended Use
Medical Device or Not?
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Medical Device Software
• Administrative support
• Wellness
• Certified EHR
• MDDS (+)
• Transparent Professional Use CDS, unlessanalyzing medical image, IVD or signalacquisition system
Unless Secretary find software is reasonably likely to have serious adversehealth consequence and issues final order
21st Century Cures Act excludes the following from thedevice definition:
§3060. Clarifying medical software regulation
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Unregulated
• General purpose IT• Educational tools,
medical textbooks• Facilitate patient
access to information• Administrative
products• Health and Wellness• Electronic Health
Records• Medical Device Data
Systems• Professional Use
Transparent CDS
EnforcementDiscretion
• Patient Portals• Trending, tracking
and sharing data withhealthcare providers
• Coaching app –support change indaily environment
• MedicationReminders
• Certain Telemedicineproducts
Regulated
• Meets definition ofMedical Device
• Accessories to amedical device
• Analyze patient-specific medicaldevice data
• Transform platforminto a medical device
• Other CDS?
What Gets Regulated?
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Medical Device DataMedical Device Data
Transfer
Medical Device DataMedical Device DataActive
Monitoring
ActivePatient
Monitoring
Control
Medical Device
ControlConnected
Medical Device
Modify Analyze
Storage Conversion
Display
Not active patient monitoring or controlling a deviceFindings by HCP w/r/t such data and results, general info about such findings and general
background info about such lab test or other device, (but no analysis or interpretation).
Unregulated under the Cures Act
Medical Device Data Systems (MDDS+)
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MDDSActive Patient Monitoring
ACTIVE MONITORING NOT ACTIVE MONITORING
A nurse telemetry station thatreceives and displays informationfrom a bedside hospital monitor inan ICU.
A device that receives and/ordisplays information, alarms, oralerts from a monitoring device ina home setting and is intended toalert a caregiver to take animmediate clinical action.
An application that transmits achild’s temperature to aparent/guardian while the childis in the nurse/health room of aschool.
An application that facilitates theremote display of informationfrom a blood glucose meter,where the user of the meter canindependently review theirglucose and glucose levels, andwhich is not intended to be usedfor taking immediate clinicalaction
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In its MMA Guidance, FDA provided examples of products for which the FDA intendsto exercise enforcement discretion. One such exemption is for mobile apps thatprovide or facilitate supplemental clinical care, by coaching or prompting, to helppatients manage their health in their daily environment
These are apps that supplement professional clinical care by facilitating behavioralchange or coaching patients with specific diseases or identifiable health conditionsin their daily environment
Mobile Medical Apps (“MMA”)“Supplemental Clinical Care” – Enforcement Discretion
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Examples:
• Apps that coach patients with conditions such as cardiovascular disease,hypertension, diabetes or obesity, and promote strategies for maintaining ahealthy weight, getting optimal nutrition, exercising and staying fit, managing saltintake, or adhering to pre-determined medication dosing schedules by simpleprompting
According to FDA Guidance, FDA believes the app can be “safely used by a patientwithout active oversight by a medical profession and, when used for seriousconditions necessitating professional medical care, use of the app is not intended toreplace or discourage seeking treatment from a health care provider.
MMA“Supplemental Clinical Care” – Enforcement Discretion
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Apps that provide simple tools for patients with specific conditions or chronic disease(e.g., diabetes, obesity, anorexia, arthritis, heart disease) to log, track, or trend theirevents or measurements (e.g., blood pressure measurements, drug intake times,diet, daily routine or emotional state) and share this information with their healthcare provider as part of a disease-management plan.
Apps that coach patients with conditions such as cardiovascular disease,hypertension, diabetes or obesity, and promote strategies for maintaining a healthyweight, getting optimal nutrition, exercising and staying fit, managing salt intake, oradhering to pre-determined medication dosing schedules by simple prompting.
Mobile apps that provide prediabetes patients with guidance or tools to help themdevelop better eating habits or increase physical activity
Mobile apps that allow a user to, collect, log, track and trend data, such as bloodglucose, blood pressure, heart rate, weight or other data from a device to eventuallyshare with a heath care provider, or upload it to an online (cloud) database, personalor electronic health record.
MMA Examples“Supplemental Clinical Care” – Exemption from Regulation
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Wellness Guidance – The “Two Step”
The Cures Act removes General Wellness Apps from the jurisdiction of theFDA if their intended use is solely related to maintaining a healthy lifestyleand not to diagnosis or treatment of any disease or condition
Unregulated or Enforcement Discretion Wellness Products per FDA Guidance
• Relates to maintaining or encouraging health/healthy activity
• Intended only for general wellness use
• Low patient safety risk
• Associates healthy lifestyle with helping reduce risk or impact of chronicdisease or condition where well established scientifically
Recent post-Cures FDA guidance confirms FDA’s intention tocontinue to subject to enforcement those products that make
two step wellness claims:
1. Intended to promote a characteristic of a healthy lifestyle(e.g., maintaining healthy weight)
2. That healthy lifestyle characteristic has been shown toreduce risk/impact of a disease or condition
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Examples of Wellness Claims
Product W promotes making healthy lifestyle choices such as getting enoughsleep, eating a balanced diet and maintaining a healthy weight, which mayhelp living well with type 2 diabetes.
Software Product Y tracks your caloric intake and helps you manage ahealthy eating plan to maintain a healthy weight and balanced diet. Healthyweight and balanced diet may help living well with high blood pressure andtype 2 diabetes.
Product Z tracks activity sleep patterns and promotes healthy sleep habits,which, as part of a healthy lifestyle, may help reduce the risk for developingtype 2 diabetes.
Claims to enhance an individual’s participation in recreational activities bymonitoring the consequences of participating in such activities, such as tomonitor heart rate or monitor frequency or impact of collisions.
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Wellness Decision Tree
Only General Wellness claims?
Claims relating to disease or condition?
Healthy lifestyle impact well understood?
“May help reduce risk or help living well”product claims?
Inherent risk to patient safety?
General Wellness Product
Not GeneralWellnessProduct
Yes No
Yes
Yes
Yes
Yes
No
No
No
No
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Examples of Wellness Claims
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Medical Device Software Recent Developments
Digital Health Innovation ActionPlan
• Publish 21st Century Cures Actimplementation guidance
• Issue CDS software guidance
• Finalize 510(k) Guidance onSoftware Changes
• Adopt the IMDRF’s Approach toClinically Evaluating SaMD
Pre-Certification Pilot
• Focus on Entity
• Streamline or eliminate pre-market review for certainsoftware devices
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Clinical Decision Support
Restates the 21st Century Curesexemption of software if a physicianuser can independently review thebasis for the recommendation
• Suggests that software that does notprovide a reasonable basis forreviewing a recommendation willalways be regulated regardless of risk
Fails to adopt IMDRF risk framework,based on:
• Significance of the informationprovided by the Software as a MedicalDevice (“SaMD”) to the health caredecision
• State of the health care situation orcondition
December 2017 FDA Draft Guidance
Missed opportunity for FDA to provide clarity for a rapidly developing industry
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Presented by
Kevin Ryan
Partner, Epstein Becker Green
(312) 499-1421
Amy Dow
Partner, Epstein Becker Green
(312) 499-1427
